NCT00785915已完成1 期
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments
研究概览
简要总结
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI): 18 to 27 kg/m 2
- •Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
- •Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.
排除标准
- •Clinically relevant disease and/or abnormalities (past or present)
- •Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
- •Use of any prescription medication within 14 days of Day 1
- •Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
- •Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1
研究组 & 干预措施
1
Experimental
干预措施: AZD6765 (Drug)
2
Placebo Comparator
given (2 subjects in each ethnic/dose group)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments
时间窗: During the study
次要结局
- Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine(During residential period)
- Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765.(During the study)
研究者
研究点 (1)
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